“Today’s decision will ensure that complex legal questions involving federal preemption are decided by federal judges, not lay juries.”
—Cory Andrews, WLF Senior Litigation Counsel

(Washington, DC)—The U.S. Supreme Court today held that whether “clear evidence” exists that the Food and Drug Administration (FDA) considered and rejected a drug manufacturer’s request to alter its label is a question for the trial judge, not for the jury. The high court vacated the Third Circuit’s opinion and remanded the case for further consideration in light of today’s ruling. The decision marks a victory for WLF, which filed an amicus curiae brief in the case arguing that the FDA’s action preempted the manufacturer’s liability under state tort law.

The case arises from a multi-district litigation (MDL) combining lawsuits by more than 1,200 users of Fosamax, an FDA-approved prescription drug for treating osteoporosis in older woman. When Merck—the maker of Fosamax—learned of studies suggesting a possible link between long-term Fosamax use and an unusual type of thigh-bone fracture, it sought the FDA’s permission to warn of that risk on Fosamax’s label. But after reviewing all the available scientific data, the FDA rejected Merck’s revised label while it studied the issue more closely. Nonetheless, Fosamax users who suffered thigh-bone fractures sued Merck under state tort law for failing to adequately warn of their injuries.

Merck successfully argued in the MDL that because the only way it could avoid liability under state law was to violate federal law by misbranding Fosamax with an FDA-rejected label, the plaintiffs’ claims were preempted. But the U.S. Court of Appeals for the Third Circuit disagreed. It held that a reasonable jury could find that the FDA might have approved a differently worded label, so the question of preemption is one for a jury, not the court. It also held that Merck must prove its preemption defense by a “clear-and-convincing-evidence” standard of proof.

WLF’s brief argued that by focusing on what the FDA might have done rather than on what the FDA did, the appeals court’s decision dilutes Levine beyond all recognition. As the record shows and the government itself has confirmed, the FDA’s rejection of Merck’s proposed label turned solely on the available scientific data, not on Merck’s choice of words.

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